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# Prostate Ablation Device Investigation Guidance
- URL: https://www.fdaweb.com/prostate-ablation-device-investigation-guidance/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144411

FDA has issued a draft guidance, *Clinical Investigations for Prostate Tissue Ablation Devices*, with recommendations for **(1)** complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation, and **(2)** collecting clinical data to support marketing submissions for new types of prostate tissue ablation devices. The [document](https://www.fda.gov/media/128263/download?ref=fdaweb.com) does not address intended uses for treating a specific disease such as prostate cancer or benign prostatic hyperplasia. It also does not address recommendations or other requirements for non-clinical testing, training, or labeling of prostate tissue ablation systems.

The guidance scope is limited to the clinical investigations to support marketing authorization for general indications of prostate tissue ablation systems.